For Patients

Vectical (calcitriol ointment) topical (for the skin) is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults. It is a form of Vitamin D. Common side effects include pain, burning, itching, redness, or peeling at the application site.

Apply Vectical Ointment to affected areas twice daily, morning and evening. The maximum weekly dose should not exceed 200 grams. Vectical may interact with other medicines to treat psoriasis, vitamin or mineral supplements that contain calcium or vitamin D, or diuretics (water pills). Tell your doctor all medications and supplements you use. During pregnancy, Vectical should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Vectical (calcitriol ointment) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using calcitriol topical and call your doctor at once if you have any of these serious side effects:

blistering, or severe redness, itching, or other irritation of treated areas; or

worsened symptoms or no improvement in psoriasis.

Using calcitriol topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, constipation, loss of appetite, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

Less serious side effects may include mild itching or skin discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS: Pain, burning, itching, redness, or peeling at the application site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Because clinical studies are conducted under widely varying conditions, adverse
reaction rates observed in the clinical studies of a drug cannot be directly
compared to rates in the clinical studies of another drug and may not reflect
the rates observed in practice.

Clinical Studies Experience

VECTICAL (calcitriol ointment) Ointment was studied in two vehicle-controlled studies (419 subjects),
and in one open label study (324 subjects). The table below describes exposure
to VECTICAL (calcitriol ointment) Ointment in 743 subjects, including 239 exposed for 6 months and
116 exposed for one year.

Selected Adverse Events Occurring in at least 1% of Subjects
in the Two Pooled Vehicle-Controlled Studies

Vectical Ointment
(n=419)

Vehicle Ointment
(n=420)

Discomfort skin

3%

2%

Pruritus

1%

1%

Among subjects having laboratory monitoring, hypercalcemia was observed in
24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects
exposed to vehicle, however the elevations were less than 10% above the upper
limit of normal [see WARNINGS AND PRECAUTIONS]

The open label study enrolled 324 subjects with psoriasis who were then treated
for up to 52 weeks. Adverse events reported at a rate of greater than or equal
to 3% of subjects treated with VECTICAL (calcitriol ointment) Ointment were lab test abnormality (8%),
urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and pruritus (3%).
Kidney stones were reported in 3 subjects and confirmed in two.

Postmarketing Experience

The following adverse reactions have been identified during world-wide post-approval
use of VECTICAL (calcitriol ointment) Ointment: acute blistering dermatitis, erythema, pruritus, skin
burning sensation, and skin discomfort. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.